Will Following the Regulatory Script for GMOs Promote Public Acceptance of Gene-Edited Crops?

Abstract

Risk-disproportionate regulation of gene-edited crops has been proposed to gain public acceptance for this breeding technique. However, confounding safety regulations with advocacy for an underlying technology risks weakening achievement of both objectives. Dedicated factual communication and education from trusted sources is likely to better support public acceptance of gene-edited crops. Risk-disproportionate regulation of gene-edited crops has been proposed to gain public acceptance for this breeding technique. However, confounding safety regulations with advocacy for an underlying technology risks weakening achievement of both objectives. Dedicated factual communication and education from trusted sources is likely to better support public acceptance of gene-edited crops. Along with the air we breathe and the water we drink, food is required for human survival. It is predicted that food requirements will rise significantly in the coming decades in response to an increasing population and the need to provide for adequate dietary nutrition across the globe [1The Food and Agricultural Organization How to Feed the World in 2050.in: Discussion Paper. High-Level Expert Forum. FAO, 2009Google Scholar, 2United Nations. World Population Prospects. Key Findings and Advanced Tables. The 2015 Revision, UN Department of Economic and Social Affairs, Population Division.Google Scholar]. The world population is expected to grow from its current level of 7.7 billion people to 9.7 billion people by 2050 [2United Nations. World Population Prospects. Key Findings and Advanced Tables. The 2015 Revision, UN Department of Economic and Social Affairs, Population Division.Google Scholar]. This population increase, in combination with the predicted improvement in the economic status of the population, is expected to require food production to increase by a staggering 70%. This increase in food will largely need to come from increased yield per land area, rather than increased land area dedicated to agriculture, because of both land availability and the need to protect the environment. The increase in population and trend toward urbanization will reduce the land area available to grow crops, and the benefits of land spared for native habitats will become even more critical to combat the greenhouse gases exacerbating climate change. Such increases in crop productivity will necessarily include improvement in the genetics of crop varieties that match or exceed the increases realized using traditional breeding in the past. Modern biotechnology (e.g., transgene insertion and gene editing) has contributed significantly to these agricultural productivity gains and is expected to continue to do so [3Klümper W. Qaim M. A meta-analysis of the impacts of genetically modified crops.PLoS One. 2014; 9e111629Crossref PubMed Scopus (454) Google Scholar]. It is therefore imperative for these innovative technologies to be widely embraced. Mandatory premarket safety assessment of gene-edited crops under statutes currently in place for genetically modified crops has been criticized as not being risk-based owing to the similarity of the resulting crop varieties to those produced through traditional breeding [4Smyth S.J. Lassoued R. Agriculture R&D implications of the CJEU’s gene-specific mutagenesis ruling.Trends Biotechnol. 2019; 37: 337-340Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar]. Traditional breeding often includes induction of, and/or selection for, mutations that similarly edit the crop genome, but traditionally bred varieties are rarely assessed by government authorities for safety because of the remarkable track record of safety previously observed [5Schnell J. et al.A comparative analysis of insertional effects in genetically engineered plants: considerations for pre-market assessments.Transgenic Res. 2015; 24: 1-17Crossref PubMed Scopus (91) Google Scholar, 6Bradford K.J. et al.Regulating transgenic crops sensibly: lessons from plant breeding, biotechnology and genomics.Nat. Biotechnol. 2005; 23: 439-444Crossref PubMed Scopus (183) Google Scholar]. However, some have recently suggested that the burdensome regulatory oversight currently in place for genetically modified crops (averaging 35 million US dollars to complete for an internationally traded commodity [7McDougall P. The cost and time involved in the discovery, development and authorisation of a new plant biotechnology derived trait. A Consultancy Study for Crop Life International.http://www.croplife.org/PhillipsMcDougallStudyDate: 2011Google Scholar]) will instill consumer acceptance for gene-edited crops, and as such, strict government oversight is warranted [8Ishii T. Crop gene-editing: should we bypass or apply existing GMO policy?.Trends Plant Sci. 2018; 23: 947-950Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar]. This position is at odds with the history of regulatory oversight for genetically modified crops where arduous regulation has likely contributed to public distrust [9McFadden B.R. Examining the gap between science and public opinion about genetically modified food and global warming.PLoS One. 2016; 11e0166140Crossref PubMed Scopus (26) Google Scholar]. Over-regulation of genetically modified crops likely has only reinforced any public perceptions that genetically engineered crops are risky, when in fact, risks are similar to those for traditional breeding, which itself has a good history of safety [10Herman R.A. et al.Risk-only assessment of genetically engineered crops Is risky.Trends Plant Sci. 2019; 24: 58-68Abstract Full Text Full Text PDF PubMed Scopus (16) Google Scholar]. For example, the introduction of transgenes into a crop variety through genetic engineering causes fewer unexpected changes to the biochemical composition of a crop and these changes are of a lower magnitude compared with traditional methods of variety development (although such changes carry negligible risk irrespective of the breeding method) [11Herman R.A. et al.Stacking transgenic event DAS-Ø15Ø7-1 alters maize composition less than traditional breeding.Plant Biotechnol. J. 2017; 15: 1264-1272Crossref PubMed Scopus (21) Google Scholar]. Excessive oversight for contentious but low-risk technologies can contribute to public distrust and historically has failed to foster public acceptance (e.g., the use of food irradiation to prevent food-borne illness [12Farkas J. Mohácsi-Farkas C. History and future of food irradiation.Trends Food Sci. Technol. 2011; 22: 121-126Crossref Scopus (267) Google Scholar]). Successful (but not universal) public acceptance of technologies, such as vaccines, microwave ovens, and cell phones, has been accompanied by science-based, risk-proportionate regulations [13Falk L.A. Ball L.K. Current status and future trends in vaccine regulation — USA.Vaccine. 2001; 19: 1567-1572Crossref PubMed Scopus (18) Google Scholar] (https://www.govinfo.gov/app/details/CFR-2012-title21-vol8/CFR-2012-title21-vol8-sec1030-10; https://www.fda.gov/radiation-emittingproducts/radiationemittingproductsandprocedures/homebusinessandentertainment/cellphones/default.htm). Would a hypothetical requirement by government regulators for vaccine providers to test new vaccines for their potential to cause autism likely change the position of members of the public that fear this outcome for their children? Alternatively, would risk-disproportionate regulation of this kind be seen by this segment of the population as a validation of their fears and therefore reinforce public distrust of contentious but safe technologies? Confounding the mission of a regulatory agency to assess a specific product to protect public safety with an additional mission to foster public acceptance of the underlying technology carries risks. These risks include diluting or confusing the purpose of risk assessment to protect public safety with a mission of advocating for an underlying general technology such that real safety risks are not readily distinguished from negligible risks in the sea of data reported to meet regulatory requirements. An additional risk is that the time and cost of gaining arduous non-risk-based regulatory approvals will obstruct developers from bringing to market greatly beneficial technologies that provide public good. Education and outreach are a better use of limited government resources in the support of public acceptance of beneficial technologies. However, it should be recognized that those with the strongest anti-technology stances, such as being against genetically modified organisms, often falsely believe that they know the most about the subject and are frequently closed to new information [14Fernbach P.M. et al.Extreme opponents of genetically modified foods know the least but think they know the most.Nat. Human Behav. 2019; 3: 251-256Crossref PubMed Scopus (105) Google Scholar]; thus, educational efforts will be most effective when targeting those that are willing to consider new information when reaching conclusions. Copious factual communications from trusted sources are critical (but likely not sufficient alone) to countering the misinformation commonly spread by certain advocacy groups, especially via social media where many seek information [15Herman R.A. et al.GE crops are seen through a warped lens.Scientist. 2019; 33: 22Google Scholar]. Deconvoluting the goal of regulating technologies to protect public safety from the goal of achieving public acceptance of beneficial technologies may help avoid the risk that neither goal will be successfully met.